NCT07756450

Brief Summary

Textbook Outcome (TO) is a composite quality measure that integrates multiple perioperative endpoints to provide a comprehensive assessment of surgical quality. Although obesity has been associated with adverse outcomes after colorectal surgery, its impact on achieving TO remains unclear, particularly in the era of minimally invasive surgery. This study aimed to evaluate the association between body mass index (BMI) and TO achievement in patients undergoing minimally invasive colorectal cancer surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

5 years

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Minimal Invasive Colorectal Surgery

Keywords

minimal invasive colorectal surgeryobesitybody mass indextextbook outcome

Outcome Measures

Primary Outcomes (1)

  • Demographic, clinical, and perioperative characteristics

    Age, sex, comorbidity burden assessed by the age-adjusted Charlson Comorbidity Index (CCI) , ASA score , tumor location, neoadjuvant therapy, surgical approach, or postoperative complication rates

    30 days

Secondary Outcomes (1)

  • Textbook Outcome

    30 days

Study Arms (2)

non-obese grup

BMI \<30 kg/m²

obese group

BMI ≥30 kg/m²

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent minimally invasive colorectal surgery between 2021 and 2025

You may qualify if:

  • Patients who underwent curative minimally invasive colorectal cancer resection at a single tertiary referral center between 2021 and 2025 were retrospectively reviewed. All patients were ≥18 years of age.

You may not qualify if:

  • Patients undergoing metastatic resections, abdominoperineal resection (APR), Hartmann's procedure, multisegmental or total colectomy, transanal minimally invasive surgery (TAMIS), or palliative procedures were excluded from the analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital, University of Health Sciences

Istanbul, Bakirköy, 34147, Turkey (Türkiye)

Location

Related Publications (5)

  • Lara-Romero C, Vilches A, Caunedo-Alvarez A, Hergueta-Delgado P, Lavin-Castejon I, Andrade-Bellido R, Alcain-Martinez G. Better recurrence-free survival after stent bridge to surgery compared to emergency surgery for obstructive left-sided colonic cancer in patients with stage III status of the American Joint Committee on Cancer (AJCC): a bicentric retrospective study. Int J Colorectal Dis. 2019 Jul;34(7):1241-1250. doi: 10.1007/s00384-019-03318-x. Epub 2019 May 25.

    PMID: 31129696BACKGROUND

  • Hirata Y, Agnes A, Arvide EM, Robinson KA, To C, Griffith HL, LaRose MD, Munder KM, Mansfield P, Badgwell BD, Ikoma N. Short-Term and Textbook Surgical Outcomes During the Implementation of a Robotic Gastrectomy Program. J Gastrointest Surg. 2023 Jun;27(6):1089-1097. doi: 10.1007/s11605-023-05627-7. Epub 2023 Mar 14.

    PMID: 36917404BACKGROUND

  • Roh CK, Lee S, Son SY, Hur H, Han SU. Textbook outcome and survival of robotic versus laparoscopic total gastrectomy for gastric cancer: a propensity score matched cohort study. Sci Rep. 2021 Jul 28;11(1):15394. doi: 10.1038/s41598-021-95017-3.

    PMID: 34321568BACKGROUND

  • Bolger JC, Al Azzawi M, Whooley J, Bolger EM, Trench L, Allen J, Kelly ME, Brosnan C, Arumugasamy M, Robb WB. Surgery by a minimally invasive approach is associated with improved textbook outcomes in oesophageal and gastric cancer. Eur J Surg Oncol. 2021 Sep;47(9):2332-2339. doi: 10.1016/j.ejso.2021.03.240. Epub 2021 Mar 17.

    PMID: 33766456BACKGROUND

  • Busweiler LA, Schouwenburg MG, van Berge Henegouwen MI, Kolfschoten NE, de Jong PC, Rozema T, Wijnhoven BP, van Hillegersberg R, Wouters MW, van Sandick JW; Dutch Upper Gastrointestinal Cancer Audit (DUCA) group. Textbook outcome as a composite measure in oesophagogastric cancer surgery. Br J Surg. 2017 May;104(6):742-750. doi: 10.1002/bjs.10486. Epub 2017 Feb 27.

    PMID: 28240357BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 10, 2026

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion

April 15, 2026

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)